FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
64380-742
11-digit product format
643800742
Labeler code
64380
Product ID
64380-742_8b51cc64-78c9-4457-a523-161bc2049bdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA202330
Marketing category
ANDA
Marketing start
2015-06-30
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 866094, 866111

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9968269-ddf2-400e-9170-7376dcf3545aProduct name120251215
2cf3c2e9-d566-c982-009a-188fe4f776b9Product name820200428
4a9096ce-7b98-89e5-5942-15f48c4f7abfProduct name520190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-742-06Buspirone Hydrochloride100 in 1 BOTTLETABLET10015
64380-742-07Buspirone Hydrochloride500 in 1 BOTTLETABLET50015
64380-742-08Buspirone Hydrochloride1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-742-06EA - Each64380-742a3d948f0-3744-428a-8d99-90de905ceecc12014-12-01
64380-742-07EA - Each64380-742098a7858-9248-4ed1-9605-9bcd7aa0d9ff12015-07-20
64380-742-08EA - Each64380-74227c84f53-8848-4fb6-a601-c194e25f438f12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
WATERINACTIVE INGREDIENT059QF0KO0RBUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-742BUSPIRONE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]14Current NDC, Legacy NDC, 3 package rows20250311_cff9f09a-1ea2-4968-b57b-e62bebaae238.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNcff9f09a-1ea2-4968-b57b-e62bebaae23815
866018busPIRone HCl 15 MG Oral TabletPSNcff9f09a-1ea2-4968-b57b-e62bebaae23815
866090busPIRone HCl 30 MG Oral TabletPSNcff9f09a-1ea2-4968-b57b-e62bebaae23815
866094busPIRone HCl 5 MG Oral TabletPSNcff9f09a-1ea2-4968-b57b-e62bebaae23815
866111busPIRone HCl 7.5 MG Oral TabletPSNcff9f09a-1ea2-4968-b57b-e62bebaae23815
866083buspirone hydrochloride 10 MG Oral TabletSCDcff9f09a-1ea2-4968-b57b-e62bebaae23815
866018buspirone hydrochloride 15 MG Oral TabletSCDcff9f09a-1ea2-4968-b57b-e62bebaae23815
866090buspirone hydrochloride 30 MG Oral TabletSCDcff9f09a-1ea2-4968-b57b-e62bebaae23815
866094buspirone hydrochloride 5 MG Oral TabletSCDcff9f09a-1ea2-4968-b57b-e62bebaae23815
866111buspirone hydrochloride 7.5 MG Oral TabletSCDcff9f09a-1ea2-4968-b57b-e62bebaae23815
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYcff9f09a-1ea2-4968-b57b-e62bebaae23815
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYcff9f09a-1ea2-4968-b57b-e62bebaae23815
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYcff9f09a-1ea2-4968-b57b-e62bebaae23815
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYcff9f09a-1ea2-4968-b57b-e62bebaae23815
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYcff9f09a-1ea2-4968-b57b-e62bebaae23815
866083busPIRone HCl 10 MG Oral TabletPSNecdfd79e-7450-40ec-9561-cdda3a0439906
866083busPIRone HCl 10 MG Oral TabletPSNbae98d45-e192-56e3-e053-2a95a90aadc36
866083buspirone hydrochloride 10 MG Oral TabletSCDbae98d45-e192-56e3-e053-2a95a90aadc36
866083buspirone hydrochloride 10 MG Oral TabletSCDecdfd79e-7450-40ec-9561-cdda3a0439906
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYbae98d45-e192-56e3-e053-2a95a90aadc36
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYecdfd79e-7450-40ec-9561-cdda3a0439906
866083busPIRone HCl 10 MG Oral TabletPSNd9de7cf1-c38d-8b3c-e053-2995a90aa26b4
866083buspirone hydrochloride 10 MG Oral TabletSCDd9de7cf1-c38d-8b3c-e053-2995a90aa26b4
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYd9de7cf1-c38d-8b3c-e053-2995a90aa26b4
866083busPIRone HCl 10 MG Oral TabletPSN093b701d-4a43-4871-b726-c5820fa3ab952
866083buspirone hydrochloride 10 MG Oral TabletSCD093b701d-4a43-4871-b726-c5820fa3ab952
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY093b701d-4a43-4871-b726-c5820fa3ab952
866083busPIRone HCl 10 MG Oral TabletPSN4d1ae09a-3ead-4604-8d13-590f41f63b961
866083busPIRone HCl 10 MG Oral TabletPSN50b18368-d37c-374b-e063-6394a90a81141
866083buspirone hydrochloride 10 MG Oral TabletSCD4d1ae09a-3ead-4604-8d13-590f41f63b961
866083buspirone hydrochloride 10 MG Oral TabletSCD50b18368-d37c-374b-e063-6394a90a81141
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY4d1ae09a-3ead-4604-8d13-590f41f63b961
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY50b18368-d37c-374b-e063-6394a90a81141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-742-0664380074206100 TABLET in 1 BOTTLE (64380-742-06) 100 tablet2015-06-300000-00-00NoNoCurrent
64380-742-0764380074207500 TABLET in 1 BOTTLE (64380-742-07) 500 tablet2015-06-300000-00-00NoNoCurrent
64380-742-08643800742081000 TABLET in 1 BOTTLE (64380-742-08) 1000 tablet2015-06-300000-00-00NoNoCurrent